Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Melanoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Ovarian Neoplasms

Vulvar Neoplasms

Anus Neoplasms

Uterine Cervical Neoplasms

Rectal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Breast Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Vulvar Diseases

Anus Diseases

Ovarian Cancer

Anal Cancer

Vulvar Cancer

Each patient receive both injections of Technetium99 (standard care) and indocyanine green.

The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)

Indocyanine green

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.

Lymphoscintigraphy is performed to identify the sentinel node

Technetium99

The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Optonuclear probe

The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

Quest Camera

MARCHAL FREDERIC, MD, PU-PH

This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively.

Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.

The total number of sentinel node detected will be assess by the two techniques

False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node

Percentage of patients with allergic reactions

Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)

The total number of sentinel node detected by fluorescence imaging

Institut de Cancérologie de Lorraine

Infections

Herpes Simplex

Virus Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

HF10

Robert L Ferris, MD, PhD

The purpose of this study is to determine whether HF10 is safe and effective in the treatment of head and neck cancer or solid tumors with cutaneous and/or superficial lesions.

This is an open label, non-randomized, multicenter, two-stage, dose escalation Phase I study evaluating single and repeated intratumoral injections of the oncolytic virus, HF10, in patients with refractory head and neck cancer, or solid tumors with cutaneous and/or superficial lesions (e.g., squamous cell carcinoma of the skin, carcinoma of the breast, and malignant melanoma).

Stage 1: Stage 1 of the study will investigate dose escalation of a single intratumoral injection over the following dose levels: 1 x 10\^5 TCID50, 3 x 10\^5 TCID50, 1 x 10\^6 TCID50, and 1 x 10\^7 TCID50. In Stage 1, it is planned that 3 patients will be enrolled per single dose cohort. Within each single dose cohort, accrual will temporarily be suspended after the first patient is entered and the patient will be followed for safety and for viral distribution and elimination. The patients in Stage 1 must be seropositive for HSV-1.

Stage 2: Stage 2 will evaluate repeated intratumoral injections of HF10 at dose levels of 1 x 10\^6 TCID50/dose and 1 x 10\^7 TCID50/dose. Three patients will be enrolled in each of the repeated dose cohorts. In Stage 2, the first patient treated in each repeated dose cohort must be seropositive for HSV-1. Patients in the repeated dose cohort will receive a total of four intratumoral injections in the same lesion.

Following completion of dosing in the repeated dose cohorts, an expansion cohort of three additional patients will be treated at the highest tolerated dose level.

Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions

Phase I Trial of Intratumoral Administration of HF10, A Replication Competent Herpes Simplex Virus Type 1, in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions

Takara Bio Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine
Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions	NCT01017185	Refractory Head... Squamous Cell C... Carcinoma of th... Malignant Melan...	HF10	18 Years -	Takara Bio Inc.
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine

Spots Global Cancer Trial Database for squamous cell carcinoma, skin